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Best Cardiac Output During Cardiopulmonary Bypass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01379638
First Posted: June 23, 2011
Last Update Posted: June 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aalborg Universitetshospital
  Purpose
The purpose of this study is to determine whether the patients cardiac output measured before cardiopulmonary bypass (CPB), is more sufficient to secure the patients oxygen needs than the estimated cardiac output from Ficks principle, and thereby prevent organ failure.

Condition
Bypass Complications

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Best Cardiac Output During Cardiopulmonary Bypass

Further study details as provided by Aalborg Universitetshospital:

Enrollment: 20
Study Start Date: December 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
cardiac output
Adult patients undergoing cardiac surgery with normothermic cardiopulmonary bypass

Detailed Description:

For more than 50 years, CPB has been used to mechanically support the functions of the heart and lungs. In early studies, systemic oxygen uptake, calculated using Ficks global principle, was used to assess the efficiency of CPB. Using this measure of efficiency, a pump flow rate in liters per minute, based on the product of the body surface area (BSA) and a constant of 2.4 was found adequate to perfuse the body during normothermia. Ficks global principle is still used together with other methods to secure adequated perfusion under CPB.

The purpose of this study is to determine whether the patients cardiac output measured before CPB, is more sufficient to secure the patients oxygen needs than the estimated cardiac output from Ficks principle, and thereby prevent organ failure.

The hypothesis is that the patients cardiac output is a better marker for the optimal cardiac output than the estimated cardiac output.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients to be admitted to Aalborg Hospital, department of cardiac surgery for scheduled cardiac surgery
Criteria

Inclusion Criteria:

  • patients admitted for scheduled cardiac surgery during cardiopulmonary bypass
  • Aged 18-90 years
  • LVEF > 50 %
  • written consent from the patients

Exclusion Criteria:

  • Former cerebral emboli
  • Former head trauma
  • known stenosis of the arteria carotis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379638


Locations
Denmark
Alborg Hospital
Aalborg, Denmark, 9100
Sponsors and Collaborators
Aalborg Universitetshospital
Investigators
Study Director: Bodil Steen Rasmussen, MD, PhD Aalborg Universitetshospital
  More Information

Responsible Party: Sisse Anette Thomassen, Department of cardiothoracic surgery and anesthesiology
ClinicalTrials.gov Identifier: NCT01379638     History of Changes
Other Study ID Numbers: N-20080035
First Submitted: June 22, 2011
First Posted: June 23, 2011
Last Update Posted: June 23, 2011
Last Verified: December 2008

Keywords provided by Aalborg Universitetshospital:
cardiopulmonary bypass
cardiac output
flow rate
lactate